Hinged therapeutic mouthpiece

ABSTRACT

This invention relates to devices for insertion into the mouth for the application of heat or cold to oral tissue to provide a therapeutic effect. The device  10  includes an upper member  11  substantially conforming to a contour of an upper gum line, a lower member  12  substantially conforming to a contour of a lower gum line, a first hinge member  13,  and a second hinge member  14,  wherein at least one hinge member  13, 14  is configured to exert a compressive force to maintain the upper member  11  substantially in contact with an upper gum and the lower member  12  substantially in contact with a lower gum.

RELATED APPLICATION

[0001] This application is a continuation of copending U.S. applicationSer. No. 10/209,310, filed Jul. 31, 2002, and claims the benefit of U.S.Provisional Application No. 60/309,327, filed Aug. 1, 2001.

FIELD OF THE INVENTION

[0002] This invention relates to devices for insertion into the mouthfor the application of heat or cold to oral tissue to provide atherapeutic effect.

BACKGROUND OF THE INVENTION

[0003] Cryoanesthesia, or the localized application of cold as a meansof producing regional anesthesia, for non-parenteral relief of pain isan accepted method for treating oral tissue. The basic physiologiceffects of cooling tissue may include decreased local metabolism,vasoconstriction, reduced swelling, decreased hemorrhage, and analgesia.The magnitude and/or type of the effect generally depends upon theapplication method and duration of the treatment. Cryoanesthesia orcryotherapy may be preferred for a variety of indications, includingdecreasing swelling or bleeding after oral surgery, to treat burns, toreduce inflammation due to allergic reaction, or to reduce pain.Conventionally, cryoanesthesia or cryotherapy involves externalapplication of ice or cold packs to the jaw or face.

[0004] Likewise, heat therapy or thermal treatments may be useful forcertain conditions of the oral tissue. For example, application of heatmay relieve painful muscle spasms or cramping, or the pain oftemporomandibular joint disease or headache. As with cryotherapy, heattherapy conventionally involves application of a hot pack or heating padto the skin of the jaw or face. The conventional methods of applyingheat or cold to oral tissue suffer the drawback that the heat or coldmust be conducted through the skin and underlying tissue to the oraltissue to be treated.

SUMMARY OF THE INVENTION

[0005] There is a need for a device and method for effectively andefficiently providing anesthesia or pain relief to the oral tissue.Specifically, a device and method that may be used to apply heat or colddirectly to a localized area of the oral tissue may be especiallydesirable.

[0006] One aspect of the present invention includes the realization thatoral thermal therapy can be more effective and efficient if the deviceis placed in direct contact with oral tissue that is the subject oftherapy. Indirect application of heat or cold to oral tissue is lessefficient because the thermal energy is conducted through facial skinand the underlying tissue, thereby attenuating the flow of thermalenergy into and out of the oral tissue to be treated. Thus, by directlyapplying heat or cold to a localized area of oral tissue, anesthetic andother effects can be achieved more effectively and efficiently.

[0007] The preferred embodiments of the present invention facilitate theapplication of cold to the gums, which may be especially helpful toreduce pain and swelling before, during, and after dental or otherprocedures, and for alleviating pain associated with trauma to the oralcavity. The application of cold may also provide relief from mouth soresand headaches, and may be helpful in pretreatment for certainprocedures. The device of preferred embodiments may offer a significantadvantage over ice cubes, cold drinks, and the like, because itlocalizes the cold to the gums or oral tissue without affecting theteeth. It is beneficial to avoid contact with the teeth since they areoften sensitive to cold. The invention also has the advantages of beingreusable and minimally invasive.

[0008] One preferred embodiment is a device that can be positionedbetween the gum line and the inner wall of the cheek. In one aspect of apreferred embodiment, two tube-like, flexible elements are curved in asemicircular shape or other shape similar to the curve of a patient'sgum line. These semicircular elements are preferably connected to eachother by two bendable hinge members. The bendable hinge members may beintegral with the semicircular elements, or may be removably attached tothe semicircular elements by an appropriate joint configuration.

[0009] When worn within the mouth, one semicircular element contacts theupper gum, one semicircular element contacts the lower gum, and thehinge members are positioned toward the back of the mouth. The thicknessof the semicircular elements is preferably selected such that theyextend over the gum area, while minimizing contact with the teeth. Thehinge members allow the device to deform slightly when a gentlysqueezing pressure is applied. Compressing the device in this wayfacilitates positioning the device in the mouth. The hinge members arealso slightly compressed during normal use, and the pressure exerted inopposition to the compression force helps the device remain in positionwithin the mouth. The hinge members preferably operate in a manner thatdoes not risk trauma to the gum or cheek area.

[0010] In one preferred embodiment of the invention, the semicircularelements are hollow and are filled with a non-toxic solution that, whencooled, still remains flexible. In an alternative embodiment, thesemicircular elements are solid and composed of a material that iscapable of retaining cold or heat without the aid of an encapsulatedsubstance. In other embodiments, a spongy material capable of retaininga cooling or heating material is utilized. In each embodiment, thesemicircular elements are preferably soft for comfort yet durable so asto avoid compromising the device if it is accidentally bitten or used inconjunction with braces, dentures, or other oral or medical devices orprocedures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011]FIG. 1a provides a rear, top, and left side perspective view of adevice of a preferred embodiment.

[0012]FIG. 1b provides a top plan view of the device of FIG. 1a.

[0013]FIG. 1c provides a rear elevational view of the device of FIG. 1a.

[0014]FIG. 1d provides a sectional view taken along line 1 c-1 c of FIG.1c.

[0015]FIG. 1e provides an enlarged view of a portion of the deviceidentified by a circle in FIG. 1d.

[0016]FIG. 2a provides a rear, top, and right side perspective view of adevice of a preferred embodiment.

[0017]FIG. 2b provides an enlarged view of a portion of the deviceidentified by a circle in FIG. 2a.

[0018]FIG. 3a provides a plan view of a device of a preferredembodiment.

[0019]FIG. 3b provides a front elevational view of the device of FIG.3a.

[0020]FIG. 3c provides a sectional view taken along line 3 a-3 a of FIG.3a.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0021] The following description and examples illustrate a preferredembodiment of the present invention in detail. Those of skill in the artwill recognize that there are numerous variations and modifications ofthis invention that are encompassed by its scope. Accordingly, thedescription of a preferred embodiment should not be deemed to limit thescope of the present invention.

[0022] Devices for use in the oral cavity to provide soothing or painrelief are described in the patent literature, for example, U.S. Pat.No. 5,819,144 “Therapeutic mouthpiece”; U.S. Pat. No. 4,983,122 “Dentalcompress”; U.S. Pat. No. 5,323,787 “Custom fitted mouthpiece w/medicatedpad and container”; U.S. Pat. No. 3,885,403 “Hot and cold compress”;U.S. Pat. No. 5,782,868 “Gel filled teething device”; U.S. Pat. No.5,606,871 “Pacifier shaped teether with cold storage container”; U.S.Pat. No. D420,447 “Teething ring”; U.S. Pat. No. D411,303 “Vibratingteething ring”; U.S. Pat. No. 5,902,322 “Vibrating teething ring”; U.S.Pat. No. 5,766,223 “Child's teething device”; U.S. Pat. No. D391,363“Teething ring”; U.S. Pat. No. 5,666,693 “Toy handle for oral device”;U.S. Pat. No. 5,653,731 “Pacifier having a shield with chewing beads”;U.S. Pat. No. 5,649,964 “Vibrating teething ring device”; U.S. Pat. No.5,606,871 “Pacifier shaped teether with cold storage container”; U.S.Pat. No. 5,551,952 “Teething ring”; U.S. Pat. No. 5,520,016 “Ring andcatch and method”; and U.S. Pat. No. 5,515,870 “Thumb and finger suckingprevention device.” Teething rings and other cold compress devices arecommercially available, including Doctor's Choice Gum Soother marketedby Danara Intl., Ltd., of North Bergen, N.J.; Playskool Ice CreamTeether marketed by Safety 1^(st), Inc. of Canton Mass.; Cooling GumSoother marketed by Babies Best, Inc., of Vernon, Calif.; and Certi CoolInstant Cold Compress marketed by Certified Safety Manufacturing, Inc.of Kansas City, Mo. Such devices may have certain drawbacks that makethem unsuitable or not preferred for use in certain applications.

[0023] In contrast, the devices of the preferred embodiments are usefulin a variety of applications, and are particularly effective inadministering cryoanesthesia to localized areas of the oral tissue.

[0024] Referring to the FIGS. 1a, 1 b, and 1 c, a preferred embodimentof a dental device 10 or mouthpiece as shown includes a lower element11, and an upper element 12 curved to fit along an average gum line.Preferably, the upper and lower elements 11, 12 are rod or tube shaped.The lower element 11 is specially shaped to conform to the lower gumline and the upper element 12 is specially shaped to conform to theupper gum line.

[0025] Elements 11, 12 are also preferably capable of deformingsufficiently to comfortably fit different gum lines. The dimensions ofelements 11, 12 are such that in an average application, the devicemaximizes contact with the gums while minimizing contact with the teeth.In various embodiments, the dimensions of the device may be adjusted asdesired to fit certain jaw sizes, e.g., children of various ages, adultwomen, adult men, and the like. Alternatively, if the device is for usein veterinary applications, the dimensions of the elements may beselected so as to provide a proper fit to the gum line of the animalbeing treated.

[0026] As depicted in FIG. 1d, the cross-sectional view along line 1 a-1a of FIG. 1c, the elements 11, 12 are hollow and have a relatively thinwall, as depicted in the enlarged view provided in FIG. 1e. Preferably,the elements 11, 12 have a maximum outer diameter of about 3 mm or lessto about 20 mm or more, preferably about 4, 5, or 6 mm to about 15, 16,17, 18, or 19 mm, more preferably about 7, 8, or 9 to about 11, 12, 13,or 14 mm, and most preferably about 10 mm.

[0027] The preferred maximum outer diameter of elements 11, 12 may vary,depending upon the characteristics and configuration of the oral cavity.Preferably, the thickness of the wall of the elements 11, 12 is lessthan about 0.5 mm to greater than about 2 mm, preferably about 0.75 mmto about 1.25 to 1.5 mm, most preferably about 1 mm. The preferredthickness may vary, depending upon the material from which the tube isfabricated. Thinner walls may facilitate heat transfer and flexibilityof the device, while thicker walls may provide improved structuralintegrity, durability, and rigidity. While tubing having a circularcross section is generally preferred, tubing having an oval orelliptical cross section, or any other suitable shaped cross section,may also be preferred.

[0028] As depicted in FIGS. 1a, 1 b, 1 c, 1 d, and 1 e the lower element11 is connected to the upper element 12 by bendable hinge members 13,14. The hinge members 13, 14 are configured to maintain a slightdownward force on element 11 against the lower gum and a slightly upwardforce on element 12 against the upper gum when the device 10 ispositioned in the oral cavity.

[0029]FIG. 2a provides detail for the hinge member depicted in thedevice of FIG. 2b. In this embodiment, elements 11, 12 are fabricatedfrom oval tubing, while the hinge members 13, 14 are fabricated fromtubing having a circular cross section. Sections of tubing 15, 16provide a transition from the oval tubing of elements 11, 12 to roundtubing of the hinge members 13, 14.

[0030] The transitions 15, 16, elements 11, 12, and hinge members 13, 14may be fabricated in any suitable or convenient manner. For example, thedifferent cross section shapes may be imposed on a unitary piece oftubing to form the transition members 15, 16, elements 11, 12, and hingemembers 13, 14. Alternatively, two or more sections of tubing or shapedpieces may be affixed or joined together to form transition members 15,16, elements 11, 12, and hinge members 13, 14.

[0031] In a hinge member 13 of one embodiment, depicted in FIGS. 3a-c,transition members 15, 16 are situated on either end of hinge member 13.The transition members 15, 16 are provided with connectors 17, 18 havingat least one annular projection 21, 22, 23. The connectors 17, 18 areconfigured to form a seal with elements 11, 12 upon insertion of theconnector 17 or 18 into a lumen at an end of element 11 or 12.Preferably, the maximum diameter of the annular projections 21, 22, 23is slightly larger than the inner diameter of the elements 11, 12, whichare constructed of a flexible material, thereby providing a secure fitafter insertion of the connectors 17, 18 into the ends of the elements11, 12.

[0032] In one embodiment, the device 10 is fabricated to have a specifichinge angle. In preferred embodiments, the hinge angle, when nocompressive force is applied, may vary from about 5° or less to about45° or more, preferably about 10° to about 40°, more preferably about15° to about 35°, and most preferably from about 20° to about 30°.

[0033] In preferred embodiments, the device is provided to thepractitioner in a ready-to-use form. However, in certain embodiments, itmay be desired by the practitioner to adjust the device prior to use.For example, it may be desirable to adjust the hinge angle so as tobetter conform the device to the shape of a particular patient's mouth,or to adjust the radius of the hinge member to increase or decrease thelength of the arch for a comfortable fit. In such embodiments, the hingemembers or other components of the device may be fabricated from amaterial that is pliable upon the application of heat, yet substantiallyresilient at room temperature. The hinge or other member may then beheated, bent into the desired shape or angle, then cooled to therebyretain its new shape.

[0034] In preferred embodiments, the material from which the hingemember is fabricated is preferably pliable yet have some degree ofrigidity such that it can be bent into a new shape and substantiallyretain that new shape in the absence of deforming forces. The materialis also preferably sufficiently resilient such that it can accommodate arange of deforming forces, for example, the natural movement of themouth, without a substantial effect on the device's resting shape (i.e.,its shape in the absence of deforming forces). Materials that arepliable at room temperature but which have memory, i.e., materials thatsubstantially return to their original shape after a deforming force isremoved, are generally preferred.

[0035] In preferred embodiments, the lower and upper elements 11, 12 areslightly compressed when the device is in position in the patient'smouth to maintain snug contact between the gum line and the inner wallof the cheek. In addition to gently holding elements 11, 12 in place,hinge members 13, 14 aid in moving the device into and out of the mouth.In a preferred embodiment, the hinge members 13, 14 and elements 11, 12are provided with an interlocking click mechanism that permits thelength of the arch to be adjusted to fit different jaw sizes. In such aconfiguration, the hinge member 11 or 12 and element 11 or 12 may bemoved apart or together then clicked in place to provide a comfortablefit.

[0036] The hinge member is preferably of a “E” shape, as depicted in theFigures. This configuration offers the benefit of improved compressionand comfortable fit when the device is in position, especially duringjaw movements, e.g., while speaking. However, in other embodiments,different hinge configurations may be preferred. For example, the hingemember may preferably be a simple “C” shape capable of exerting acompressive force. In other embodiments, the hinge member may include aleaf spring, torsional spring, or other spring, optionally incombination with a simple hinge not configured to exert a compressiveforce.

[0037] In preferred embodiments, the materials from which the device isconstructed are solid and have a satisfactory capacity for retainingheat or cold for an extended period of time while the device ispositioned in the mouth. The device may be cooled in a refrigerator orfreezer before it is positioned inside the mouth. Likewise, ifapplication of heat is desired, the material may be heated, e.g., inwarm water, a convection heating oven, a microwave oven, or the like,and then maintain its warm temperature for an extended period of timeafter it is positioned in the mouth. The material preferably is capableof maintaining its flexibility after it is chilled, if it used to cooloral tissue. Likewise, the material preferably is capable of maintainingsome degree of rigidity or form after it is heated, if it is to beutilized for warming oral tissue.

[0038] In an alternate embodiment, rather than being constructed ofsolid material, elements 11, 12 are hollow and filled with a liquid orgel that preferably is capable of maintaining its cold temperature (orwarm temperature) and flexibility (or rigidity) while in use. Thisencapsulated substance preferably is non-toxic, in case of accidentalleakage.

[0039]FIGS. 1d and 1 e illustrate a cross section of a device having aconfiguration characterized by the internal fluid or gel chambers 19, 20of elements 11, 12. In a preferred embodiment, the encapsulatedsubstance is a two-phase system, for example, glycerol in water. In aparticularly preferred embodiment, a 10% glycerol solution in water isemployed. Also suitable for use is a 5 wt. % saline (NaCl) solution. Anysuitable liquid or gel may be used, however, including but not limitedto water, or water in combination with a non-toxic gelling substance.

[0040] For ease of fabrication, it is preferred to construct the twotube-like elements 11, 12 from commercially available tubing of anacceptable diameter cut to an appropriate length. Such tubing generallyhas a circular cross-section. However, in certain embodiments it may bedesired to utilize tubing having a different cross-sectional shape, forexample, elliptical, semicircular, oval, square, triangular, orirregular shape. Likewise, it may be desired for the cross sectionalshape and/or area to vary along the length of the element. For example,it may be desirable to utilize a smaller cross-sectional area and/or athinner profile in areas adjacent to the lips, and a largercross-sectional area and/or a thicker profile in areas adjacent to thecheeks. Similarly, the thickness of the wall of the tube may be variedas desired, e.g. to provide a greater or lesser degree of flexibility orto facilitate transfer of heat or cold from the device to the oraltissue.

[0041] In certain embodiments, it may be desired to apply heat or coldto a only one region of the mouth, for example, only the upper gums, thelower gums, the area adjacent to the back teeth, the area adjacent tothe front teeth, one side of the mouth, a particular tooth or teeth, oneor both hinges of the jaw, or the like. In such embodiments, it may bedesired to provide a tubular material comprising the tube-like elements11, 12 or hollow bendable hinge members 13, 14 with one or more septumsin the lumen of the member. The septum or septums delineate an area orareas to be filled with a liquid or gel that is capable of maintainingits cold temperature, with the remaining areas encapsulating air oranother material of lower heat capacity than the gel or liquid.Alternatively, elements 11, 12, 13, and/or 14 may comprise compositematerials. In such embodiments, a portion of a high heat capacity solidpolymer or other material may be secured to a portion of lower heatcapacity, e.g., a hollow air-filled tube or a polymeric material withlower heat capacity. In a particularly preferred embodiment, one or bothof elements 11, 12 may comprise a high heat capacity structure (e.g., asolid or spongy polymeric material or tube containing a cooling orheating gel or liquid), while the hinge members 13, 14 comprise hollowpolymeric structures.

[0042] In some embodiments, the hinge members 13, 14 do not directlycontact the gum line, and thus do not need to stay cold (or warm). Byway of specific example, the embodiment depicted in FIG. 1d whereelements 11, 12 are hollow, the internal fluid or gel chambers 19, 20need not extend through the hinge members 13, 14 if cooling of thecooling of the hinge members is not preferred. In other embodiments, thehinge members 13, 14 may be formed integral with elements 11, 12 duringthe molding of the plastic material.

[0043] The devices of the preferred embodiments can be advantageouslymade from any of a variety of medical grade or biocompatible materials,including ceramics, metals, polymers (such as homopolymers, copolymers,terpolymers, chemically or otherwise modified polymers, cross-linkedpolymers, coated polymers, resins, mixtures and combinations of polymersand the like), composites, and the like, which are well known to thoseof skill in the medical device manufacturing arts, includingpolytetrafluoroethylene (marketed under the tradename TEFLON™, availablefrom E.I. du Pont de Nemours and Company of Wilmington, Del.), variousdensities of polyethylene, nylon, polyethylethylketone (PEEK),polyethylene terephthalate (PET), polyether block amide copolymer(PEBAX), polymethylmethacrylate (PMMA), polytetrafluoroethylene (PTFE),polyurethane, polvvinylchloride (PVC), polydimethylsiloxane (PDMS),silicones, resin copolymers, and other materials known in the art. In aparticularly preferred embodiment, the polymeric material comprises astyrenic copolymer (marketed under the tradename KRATON™, available fromKraton Polymers of Houston, Tex.). Also preferred are siliconeelastomers in the 20 to 70 Shore A hardness range, available from GESilicones. Particularly preferred polymeric materials have a Shore Ahardness of about 10 or less to about 80 or more, preferably about 15,20, 25, or 30 to about 60, 65, 70, 75, 80, or 85, more preferably about30 or 35 to about 50 or 55, and most preferably about 40 to about 45.

[0044] Any of a variety of additional materials may also be used.Suitable manufacturing methods and apparatus are also well knownincluding injection molding and extrusion of the polymers andcombination of polymers. Selection of suitable materials can be readilyaccomplished by those of skill in the art, taking into account thedesired physical properties of the finished device, as well as thedesired manufacturing process and other product design considerationssuch as one time use.

[0045] Desired temperatures for the therapeutic application of heat orcold generally range from just above body-temperature (+37° C.) forheat-therapy to just above freezing (+0° C.) for cold-therapy. When heatis applied to the oral tissue, the temperature is preferably from about38° C. to about 49° C., more preferably from about 39, 40, or 41° C. toabout 46, 47, or 48° C., and most preferably from about 42 or 43° C. toabout 44 or 45° C. When cold is applied to the oral tissue, thetemperature is preferably from about 4° C. to about 15° C., morepreferably from about 5, 6, 7, or 8° C. to about 11, 12, 13, or 14° C.,and most preferably from about 9° C. to about 10° C. While these rangesare typically preferred for the application of cold or heat,respectively, in certain embodiments temperatures outside of theseranges may be preferred.

[0046] Heat may be generated within the device by an exothermic reactionor phase change, or may be transferred from a pre-heated mouthpiece toadjacent oral tissue. Likewise, cold may be generated by an endothermicreaction or phase change, or may be transferred to adjacent oral tissuefrom a pre-cooled mouthpiece.

[0047] In certain embodiments, it may be preferred that heating orcooling be provided without the need for increasing or reducing thetemperature of the mouthpiece by external means prior to insertion intothe mouth. In such embodiments, the mouthpiece is maintained at ambienttemperature but yields heat or cold when desired after initiation of achemical reaction, e.g., by mixing two chemical components maintained inseparate compartments in the mouthpiece, e.g., by piercing or otherwiserupturing a septum between the compartments. In other embodiments, itmay be preferred to apply heat or cold after the mouthpiece is removedfrom a cooling or heating device. In such embodiments, a high heatcapacity substance or a phase change material is preferably used. Anexample of a common phase change material is ice, however othermaterials, such as encapsulated gels as are known in the art may also beused. In other embodiments, it may be preferred to generate heat withinthe device by non-chemical means, e.g., a resistive heating unit (eitherbattery operated or provided with an external power source) incorporatedinto the device.

[0048] It may be desired to reuse the device after appropriatedisinfecting procedures. In such embodiments, the device may be capableof reuse after a regeneration process, such as reheating, recooling, orthe like. Alternatively, if the device is adapted to be discarded aftera single use, then an irreversible system may be employed, i.e., anendothermic or exothermic chemical reaction between two mixedcomponents.

[0049] In a preferred embodiment wherein pre-cooling of the device byexternal means is not desired, cooling is applied via asodium-acetate-hydrate phase change system contained within the device.The system comprises a sodium acetate aqueous solution in metastableequilibrium at ambient temperature and pressure, which undergoes a phasechange upon addition of seed crystals or a pressure pulse. Pure sodiumacetate is a water-soluble food-grade salt which forms a hydratecompound with water in an endothermic reaction. The reaction may bereversed by heating.

[0050] Heating may be applied by using a heating system comprising waterand anhydrous calcium chloride salt. When mixed, an exothermic reactionoccurs. Heat may also be generated by an oxidative exothermic process,e.g., oxidation of iron powder to iron oxide in the presence of awater-charcoal-salt-cellulose gel. In preferred embodiments wherein heatis to be applied, a paraffinic material such as hexadecane is used. Suchmaterials provide a more comfortable temperature level than most othersystems, and are generally non-toxic.

[0051] In certain embodiments, it may be preferred to incorporate arubber-like polymeric material into the device. The term “rubber-like,”as used herein, is a broad term and is used in its ordinary sense,including, without limitation, a polymeric material exhibiting memory. Apolymeric material exhibiting memory returns to its original shape whena deforming force is removed. Examples of rubber-like materials include,but are not limited to, chloroprene rubber, neoprene, styrene butadienerubber, acrylonitrile butadiene rubber, ethylene propylene dienemethylene (EPDM), and plastics such as polyvinylchloride andpolyethylene that are compounded and cured to impart rubber-likeproperties.

[0052] Such rubber-like materials may be solid or spongy. Spongymaterials possess a cellular structure. Spongy materials may generallybe divided into two classes: open cell and closed cell. Open-cellsponges possess an interconnected cell structure that permits theabsorption and circulation of gases and liquids. The open-cell structurepermits the spongy material to absorb and retain a heating or coolingmaterial. Closed cell sponges incorporate a plurality of encapsulatedpockets containing air or another gaseous material. Because the poresare not interconnected, absorption of gases and liquids by the materialis minimal.

[0053] In various embodiments, spongy materials of varying density maybe used. For example, if it is desired that the device incorporate anopen cell sponge, wherein the sponge absorbs a cooling or heatingmaterial, e.g., cool or warm water, prior to insertion into the oralcavity, it may be preferred to utilize a sponge with a low density.Alternatively, if the device contains a closed cell sponge, and thepolymeric material of the sponge is pre-cooled or pre-heated prior toinsertion into the oral cavity, a high density sponge may be preferredbecause of the greater heat capacity of the polymeric material comparedto the encapsulated gas.

[0054] In another embodiment, the device is configured to permitcirculation of a cooling or heating medium at a desired temperaturethrough the device. In such an embodiment, the device preferablyincorporates an outer wall enclosing a lumen, wherein the lumen isinterrupted at a single point on the cross section of the lumen by aseptum, with an ingress and an egress into the luminal space provided oneither side of the septum. The cooling or heating medium is supplied tothe device via the ingress from a heating or cooling source and removedvia the egress. If a high degree of temperature control is desired, theheating or cooling source may incorporate a reservoir containing thecooling or heating medium, a means for heating or cooling the medium,e.g., a resistive heating coil or a cooling jacket, a thermostat, apump, a supply line connecting the reservoir to the ingress, and adischarge line from the egress back to the reservoir. Alternatively, ifa high degree of temperature control is not desired, the ingress may beconnected to a supply of warm or cold tap water, and the egressconnected to a drain.

[0055] In yet another embodiment, the device is configured to permitdelivery of a medicament or other desired substance to the tissueadjacent to the device. In such an embodiment, the device preferablyincorporates a permeable outer wall enclosing a lumen, wherein the lumenis filled with a medicament or medicament-containing substance. Salivapresent in the mouth results in a fluid communication between the lumenand the surrounding oral tissue through passages in the outer wall. Thisfluid communication permits the delivery of medicament to thesurrounding tissue in a controlled fashion.

[0056] The rate at which the medicament is delivered may be regulated byadjusting the porosity of the outer wall of the lumen, with a greaterdegree of porosity correlating with a faster rate of delivery of themedicament. Depending upon the embodiment, the pores in the outer wallmay be large or small, or numerous or few. The desired degree and natureof the porosity may vary depending upon the medicament to be delivered,the material of the outer wall, the delivery rate of the medicament, theconcentration or amount of diluent in the lumen, and the like.Alternatively, the rate at which the medicament is delivered may beadjusted by providing the medicament in a matrix, which inhibitssolubilization, e.g., in a porous sponge, a slow-dissolving solidmatrix. The use of a matrix, diluent, or slow release system for themedicament may be preferred in certain embodiments, especially when aliquid medicament is utilized. Alternatively, the device may include asolid permeable substance with no lumen, wherein the medicament isincorporated into pores or passages of the permeable substance, or themedicament is imbedded into the material of a permeable wall.

[0057] In certain embodiments, it may be desirable to deliver both amedicament and heat or cooling to the adjacent oral tissue. In suchembodiments, the medicament may be imbedded into the wall material and acooling or heating medium contained in the lumen. Alternatively, thedevice may include a lumen divided along its length by a septum, withcooling or heating medium contained on one side of the septum, and themedicament on the other side, with the outer wall adjacent to themedicament-containing portion of the lumen provided with passages orpores permitting fluid communication with surrounding oral tissue.

[0058] Various combinations of materials or composite materials, e.g.,layered materials or laminates, may be utilized, depending upon thedesired effect.

[0059] It is generally preferred to apply cold to oral tissue using adevice of a preferred embodiment for a period of about 1 minute or lessto about 20 minutes or longer, preferably about 2, 3, or 4 minutes toabout 10 or 15 minutes, most preferably about 5 or 6 minutes to about 7,8, or 9 minutes. If desired, one or more additional cold treatments maythen be applied. It is generally preferred to provide an interval ofseveral minutes to half an hour between treatments, however in certainembodiments no interval or a longer interval may be desirable.

[0060] The devices of the various preferred embodiments are suitable fora variety of preoperative and postoperative uses. For example,preoperative uses may include, but are not limited to, the treatment ofpreexisting pain, swelling, infection, or trauma in the oral cavity.Postoperative uses include treatment of general discomfort followingperiodontal procedures, orthodontic procedures, endodontic procedures,oral and maxillofacial surgery, and general dentistry.

[0061] The devices of preferred embodiments can be useful in thetreatment of maxillofacial and orofacial pain; in regional anesthesiaapplications; in applications involving nerve blocks without collateralnumbness; in applications where the patient is endentulous, allergic toepinephrine or other analgesics, or has high blood pressure or heartproblems; and in applications where there is failed local anesthesia,pain from implantables, leucocytosis with chronic pain, masticatorymuscle hyperfunction, neuropathic pain, peripheral nerve injury, facialneuralgia, temporal mandibular disease, jaw joint pain, painful oralsores, oral mucositis pain, ondotostomatological pain, masticatorymuscle pain, root canals, severe toothache, extraction, deep scaling,root planing, and orthognathia and micrognathia with surgicalreconstruction. While the devices are particularly preferred for thenon-parenteral relief of pain by cryoanesthesia, the devices are alsosuitable for use in conjunction with conventional anesthetics,including, but not limited to, topical anesthetics, injectedanesthetics, and any other suitable means of inducing anesthesia. Issuesconnected with the use of anesthesia in the oral cavity are discussed inthe following references: Frank U, et al., “Vascular and cellularresponses of teeth after localized controlled cooling,” Cryobiology,December 1972, 9(6):526-33; Hutchings M L, “Nerve Damage and nerveblocks,” J. Am. Dent. Assoc., January 1996; 127(1):25, Ellis S,“Sedation in general practice,” Br. Dent. J., Feb. 10, 1996, 180(3):88;Nist R A, et al., “An evaluation of the incisive nerve block andcombination inferior alveolar and incisive nerve blocks in mandibularanesthesia,” J. Endod., September 1992, 18(9):455-9; Meier E,“Anesthesia problems in dentistry,” Schweiz Monatsschr. Zabrimed., 1993,103(2):205-7, 232-4; Jofre J, et al., “Design and preliminary evaluationof an extraoral Gow-Gates guiding device,” Oral Surg. Oral Med. OralPathol. Oral Radiol. Endod., June 1998, 85(6):661-4; Martof A B,“Anesthesia of the teeth, supporting structures, and oral mucousmembrane,” Otolaryngol. Clin. North Am., August 1981, 14(3):653-68;Weathers A, “Taking the mystery out of endodontics, Part 6. Painlessanesthesia for the “hot” tooth,” Dent. Today, December 1999,18(12):90-3; Meechan J G, “How to overcome failed local anaesthesia,”Br. Dent. J., Jan. 9, 1999, 186(1):15-20; Lepere A J, “Maxillary nerveblock via the greater palatine canal: new look at an old technique,”Anesth. Pain Control Dent., 1993 Fall, 2(4):195-7; Noisser H O, et al.,“Management of chronic pain conditions—anesthesiologic aspects,”Chirurg., December 1983, 54(12):785-8; Henthorn R W, et al., “A reliablemethod of testing regional block,” Reg. Anesth., March-April 1993,18(2):139; Davies M W, et al., “Anaesthetic techniques for chair dentalanaesthesia,” Anaesthesia, October 1995, 59(10):922-3; Quinn J H,“Inferior alveolar nerve block using the internal oblique ridge,” J. Am.Dent. Assoc., August 1998, 129(8):1147-8; Gomolka K A, “The AMSA block:local anesthesia without collateral numbness,” CDS Rev., October 2000,93(7):34; Franklin L K, “Electronic dental anesthesia: an injection-freealternative—a review,” Pract. Periodontics Aesthet. Dent.,January-February 1997, 9(1):103-4, 106; Dhanji A R, “Overcoming failedlocal anaesthesia,” Br. Dent. J., Apr. 10, 1999, 186(7):316-7; Thomas JA, “Anesthetizing the dental pulp,” Endod. Rep. 1992, 7(2):6-8; Young ER, et al., “Successful mandibular anesthesia following numerousunsuccessful attempts: a case report,” J. Can. Dent. Assoc., October1993, 59(10):845-50; Hannington-Kiff J G, “Cryoanalgesia forpostoperative pain,” Lancet, Apr. 12, 1980, 1(8172):829; Carpentier P,Rev. Odontostomatol. (Paris), November-December 1985, 14(6):453-8,(French); DeWitt K, “What . . . another injection technique,” J. Wis.Dent. Assoc., January 1984, 60(1):22-3; Hawkins P L, “The seconddivisions block: an easy cure for the “difficult to numb” patient,” GMDABull., March 1987, 54(3):91-2; Gaillard M M, et al., “New techniques ofloco-regional anesthesia. What are they worth?” Inf. Dent., Nov. 10,1988, 70(39):3901-6; Hogarth D L, “Maxillary nerve block anaesthesia,”Aust. Dent. J., August 1991, 36(4):326; Durick R J, “The third andsecond divisions of the trigeminal nerve: dental considerations,” J.Tenn. Dent. Assoc., April 1995, 75(2):18-22.

[0062] The preferred embodiments have been described in connection withspecific embodiments thereof. It will be understood that it is capableof further modification, and this application is intended to cover anyvariations, uses, or adaptations of the invention following, in general,the principles of the invention and including such departures from thepresent disclosure as come within known or customary practices in theart to which the invention pertains and as may be applied to theessential features hereinbefore set forth, and as fall within the scopeof the invention and any equivalents thereof. Each reference citedherein, including but not limited to patents and technical literature,is hereby incorporated by reference in its entirety.

What is claimed is:
 1. An apparatus for insertion into the oral cavity,the apparatus comprising an upper member substantially conforming to acontour of an upper gum line, a lower member substantially conforming toa contour of a lower gum line, a first hinge member configured toprovide a compressive force, and a second hinge member configured toprovide a compressive force, wherein the first hinge member joins afirst end of the upper member to a first end of the lower member,wherein the second hinge member joins a second end of the upper memberto a second end of the lower member, wherein when the apparatus isinserted into a patient's mouth, the compressive force maintains theupper member substantially in contact with an upper gum and the lowermember substantially in contact with a lower gum over a range ofrelative motion of the upper gum and lower gum.
 2. An apparatus forinsertion into the oral cavity, the apparatus comprising an upper membersubstantially conforming to a contour of an upper gum line, a lowermember substantially conforming to a contour of a lower gum line, afirst hinge member, and a second hinge member, wherein at least onehinge member is configured to provide a compressive force.
 3. Thatapparatus of claim 2, wherein at least one of said members comprises apolymeric material.
 4. The apparatus of claim 3, wherein the impermeablematerial encapsulates a gel or a liquid.
 5. The apparatus of claim 2,wherein a member selected from the group consisting of the upper member,the lower member, the first hinge member, and the second hinge membercomprises a sponge.
 6. The apparatus of claim 5, wherein the spongecomprises a polymeric material selected from the group consisting ofchloroprene rubber, neoprene, styrene butadiene rubber, acrylonitrilebutadiene rubber, ethylene propylene diene methylene, polyvinylchloride,polyethylene, and combinations thereof.
 7. The apparatus of claim 5,wherein the sponge comprises a closed cell sponge.
 8. The apparatus ofclaim 5, wherein the sponge comprises an open cell sponge.
 9. Theapparatus of claim 2, comprising a biocompatible material.
 10. Theapparatus of claim 2, comprising an impermeable material.
 11. Theapparatus of claim 3, wherein the polymeric material is pliable.
 12. Theapparatus of claim 11, wherein the polymeric material is selected fromthe group consisting of polyethylene, nylon, polyethylethylketone,polyethylene terephthalate, polyether block amide copolymer,polymethylmethacrylate, polytetrafluoroethylene, polyurethane,polyvinylchloride, polydimethylsiloxane, styrenic copolymer, andcombinations thereof.
 13. An apparatus for insertion into the oralcavity, the apparatus comprising an upper member substantiallyconforming to a contour of an upper gum line hinged to a lower membersubstantially conforming to a contour of a lower gum line so thatrotation of said upper member towards said lower member about said hingeprovides a compression force between said upper and lower member.
 14. Amethod of delivering a medicament to an oral tissue, the methodcomprising the steps of: providing an apparatus comprising an uppermember substantially conforming to a contour of an upper gum, a lowermember substantially conforming to a contour of a lower gum, a firsthinge member, and a second hinge member, wherein the first hinge memberjoins a first end of the upper member to a first end of the lowermember, wherein the second hinge member joins a second end of the uppermember to a second end of the lower member, wherein the apparatuscomprises a permeable outer wall enclosing a lumen, wherein the lumen isfilled with a medicament or a medicament-containing substance; insertingthe apparatus into an oral cavity; positioning the apparatus such that acompressive force is exerted by the first hinge member and the secondhinge member such that the upper member is substantially maintained incontact with the upper gum and the lower member is substantiallymaintained in contact with the lower gum over a range of relative motionof the upper gum and lower gum; and solubilizing the medicament in asaliva in fluid communication with the apparatus and the oral tissue,such that the medicament is delivered to the oral tissue.
 15. The methodof claim 14, wherein the medicament is a topical anesthetic.
 16. Themethod of claim 14, wherein the medicament comprises a liquid.
 17. Amethod of delivering a medicament to an oral tissue, the methodcomprising the steps of: providing an apparatus comprising an uppermember substantially conforming to a contour of an upper gum, a lowermember substantially conforming to a contour of a lower gum, a firsthinge member, and a second hinge member, wherein the first hinge memberjoins a first end of the upper member to a first end of the lowermember, wherein the second hinge member joins a second end of the uppermember to a second end of the lower member, wherein the apparatuscomprises a medicament in a matrix which inhibits solubilization of themedicament; inserting the apparatus into an oral cavity; positioning theapparatus such that a compressive force is exerted by the first hingemember and the second hinge member such that the upper member issubstantially maintained in contact with the upper gum and the lowermember is substantially maintained in contact with the lower gum over arange of relative motion of the upper gum and lower gum; andsolubilizing the medicament in a saliva in fluid communication with thematrix and the oral tissue, such that the medicament is delivered to theoral tissue.
 18. The method of claim 17, wherein the medicamentcomprises a topical anesthetic.
 19. The method of claim 17, wherein thematrix comprises a porous sponge.
 20. The method of claim 17, whereinthe matrix comprises a slow-dissolving solid.